Bedaquiline, Oral

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KEY POINTS

• This medicine is taken by mouth to treat tuberculosis. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious heart rhythm changes or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: diarylquinoline antibiotic; tuberculosis treatment

Generic and brand names: bedaquiline, oral; Sirturo

What is this medicine used for?

This medicine is taken by mouth to treat tuberculosis. It is taken along with other medicines. It is prescribed when other treatments cannot be used.

This medicine is not approved to treat an infection caused by bacteria other than TB.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart attack, heart failure, or a slow or irregular heartbeat
• HIV infection
• Kidney or liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Low levels of calcium, magnesium, or potassium in your blood
• Thyroid problems

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. You will take this medicine once per day for the first 2 weeks, then 3 times per week starting from week 3. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval, even if you feel better. You must take this medicine for a long time to treat tuberculosis.

Check with your healthcare provider before using this medicine in children under 18.

Your healthcare provider will prescribe other medicines to treat tuberculosis. Take them daily along with this medicine.

Take this medicine with food. Swallow the tablets whole with a full glass of water. Do not break, crush, or chew the tablets.

What if I miss a dose?

If you miss a dose in the first 2 weeks, skip the missed dose and take your regular dose the next day. After week 3, if you miss a dose, take it as soon as you remember. Do not take more than 6 tablets in total during a 7 day period. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or irregular heartbeat, fainting.

What should I watch out for?

In one clinical trial, more deaths were seen in people who were treated with this medicine compared to people who did not receive this medicine. Talk with your healthcare provider about this.

This medicine may cause serious heart rhythm changes. If you have a fast or irregular heartbeat or if you faint, contact your healthcare provider right away.

Your healthcare provider will want to see you regularly while you are taking this medicine. Keep all appointments.

Do not drink alcohol while taking this medicine. Alcohol increases your risk of serious side effects.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual tiredness or weakness, fever, itching, unexplained nausea or vomiting, severe stomach pain, dark urine, light-colored bowel movements, yellowing of your skin or eyes, loss of appetite, chest pain, coughing up blood, fast or irregular heartbeat, fainting.

Other: Headache, mild nausea, joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Anagrelide (Agrylin)
• Antibiotics such as cephalexin (Keflex), chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), nitrofurantoin (Furadantin, Macrobid, Macrodantin), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir (Technivie), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), simeprevir (Olysio), and sofosbuvir (Sovaldi)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), dabrafenib (Tafinlar), lapatinib (Tykerb), nilotinib (Tasigna), pazopanib (Votrient), sunitinib (Sutent), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Clofazimine (Lamprene)
• Conivaptan (Vaprisol)
• Cyclobenzaprine (Amrix)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Enzalutamide (Xtandi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), and sotalol (Betapace, Sorine)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Hydroxychloroquine (Plaquenil)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• St. John's wort

Do not drink alcohol while you are taking this medicine.

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in the original container. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.